Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02208882
Other study ID # CV004-006
Secondary ID
Status Completed
Phase Phase 1
First received August 4, 2014
Last updated July 3, 2015
Start date August 2014
Est. completion date February 2015

Study information

Verified date July 2015
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety, tolerability and effect on Midazolam pharmacokinetics of multiple oral doses of BMS-986120 in healthy subjects.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

1. Healthy male and female subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations

2. Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI=Weight (kg)/[Height(m)]2

3. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) and men, ages 18 to 75, inclusive

Exclusion Criteria:

1. Concurrent, or use within 2-weeks of study drug administration, of marketed or investigational, non-steroidal anti-inflammatory compounds (NSAIDS), aspirin or other antiplatelet agents, oral or parenteral anticoagulants

2. Subjects at screening or prior to first dose with the following abnormal laboratory values upon repeat testing are excluded:

- i) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >upper limit of normal (ULN)

- ii) Total bilirubin >ULN, thyroid-stimulating hormone (TSH) >1.5 x ULN with T4 within normal limits (Subjects with mild unconjugated hyperbilirubinemia due to Gilbert's syndrome are excluded)

- iii) CK >3 x ULN (unless exercise related and CK-MB within normal limits)

- iv) Activated partial thromboplastin (aPTT) or Prothrombin Time (PT)/International Normalized Ratio (INR) >ULN

- v) Blood urea nitrogen (BUN) or creatinine (Cr) >ULN

3. Hemoglobin or hematocrit or platelet count <lower limit of normal (LLN)

4. Bleeding time exceeding 8 minutes at pre-dose on Day -1

5. Subjects with micro- or macro-hematuria and/or fecal occult blood detected during screening, baseline or documented during other recent medical assessment, unless deemed not clinically significant by the Investigator and Medical Monitor

6. Any significant acute or chronic medical illness

7. Current or recent (within 3 months of study drug administration) gastrointestinal disease

8. Any major surgery within 12 weeks of study drug administration

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Drug:
BMS-986120

Placebo

Midazolam


Locations

Country Name City State
United States Ppd Development, Lp Austin Texas

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and tolerability measured by number of subjects experience serious adverse events, deaths, adverse events leading to discontinuation, and potential clinically significant changes in electrocardiogram (ECG) parameters Up to 168 days Yes
Primary Safety and tolerability measured by percent of subjects experience serious adverse events, deaths, adverse events leading to discontinuation, and potential clinically significant changes in electrocardiogram (ECG) parameters Up to 168 days Yes
Secondary Maximum observed plasma concentration (Cmax) of BMS-986120, BMT-141464, Midazolam, and 1`hydroxymidazolam Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22) No
Secondary Time of maximum observed plasma concentration (Tmax) of BMS-986120, BMT-141464, Midazolam, and 1`hydroxymidazolam Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22) No
Secondary Area under the concentration-time curve from time zero to 24h [AUC(TAU)] of BMS-986120 and BMT-141464 Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22) No
Secondary Concentration at the end of the dosing Interval (Ctau) of BMS-986120 and BMT-141464 Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22) No
Secondary Half-life (T-HALF) of BMS-986120 and BMT-141464 Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22) No
Secondary Apparent total body clearance (CLT/F) of BMS-986120, Midazolam, and 1`hydroxymidazolam Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22) No
Secondary AUC accumulation index (AI_AUC) of BMS-986120 and BMT-141464 Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22) No
Secondary Effective elimination half-life that explains the degree of AUC accumulation observed (T-HALFeff_AUC) of BMS-986120 Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22) No
Secondary Ratio of metabolite AUC(TAU) to parent AUC(TAU), corrected for molecular weight [MR_AUC(TAU)] of BMT-141464 Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22) No
Secondary Ratio of metabolite Cmax to parent Cmax, corrected for molecular weight (MR_Cmax) of BMT-141464 Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22) No
Secondary Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of Midazolam and 1`hydroxymidazolam Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22) No
Secondary Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of Midazolam and 1`hydroxymidazolam Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22) No
Secondary Ratio of metabolite AUC(INF) to parent AUC(INF), corrected for molecular weight [MR_AUC(INF)] of 1`hydroxymidazolam Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22) No
Secondary Change from baseline in protease-activated receptor-4 - agonist peptide (PAR4-AP) induced platelet aggregation of BMS-986120 Part A (Days 1-3) & Part B/C (Days 1-19) No
See also
  Status Clinical Trial Phase
Withdrawn NCT06034899 - A Study to Evaluate the Effect of Food on the Drug Levels of BMS-986196 in Healthy Adult Participants Phase 1
Completed NCT05162274 - Clinical Trial to Assess Bioequivalence of Lazertinib Between Two Formulations in Healthy Volunteers. Phase 1
Completed NCT03748758 - Evaluation of Safety of Repeated Doses of OP0201 Metered Dose Inhaler Compared to Placebo in Healthy Adult Volunteers Phase 1
Recruiting NCT06008652 - A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DR-0201 in Healthy Adult Volunteers Phase 1
Terminated NCT02079480 - Study to Evaluate the Safety, Tolerability, PK, and PD of BMS-986090 in Healthy Subjects Phase 1
Completed NCT01657838 - Drug Interaction Study of the Effect of Ketoconazole at Steady State on the Pharmacokinetics of a Single Dose of Isavuconazole in Healthy Adult Subjects Phase 1
Completed NCT01651325 - Drug Interaction Study of Multiple Doses of Isavuconazole and Single Dose of Dextromethorphan in Healthy Adult Subjects Phase 1
Completed NCT01354379 - Safety and Immunogenicity Study of Inactivated Nasal Influenza Vaccine NB-1008 Administered by Sprayer Phase 1
Completed NCT01129466 - Effects of 2 Different Broccoli Sprout Containing Supplements on Nasal Cells in Healthy Volunteers N/A
Completed NCT04856969 - Clinical Trial to Evaluate Pharmacokinetic Interaction of ATB-1011 and ATB-1012 in Healthy Adult Volunteers Phase 1
Completed NCT01333462 - Safety and Immunogenicity Study of Inactivated Nasal Influenza Vaccine NB-1008 Phase 1
Completed NCT02942771 - A MAD Study of TT301/MW189 in Healthy Volunteers Phase 1
Completed NCT02822898 - Metabolism of Isotonic Versus Hypotonic Maintenance Solutions in Fasting Healthy Adults Phase 4
Completed NCT05017987 - Clinical Trial to Compare Pharmacokinetics After Administration of ATB-101 or Co-administration of ATB-1011 and ATB-1012 Phase 1
Not yet recruiting NCT05757596 - Study of VSA001 Injection in Chinese Healthy Adult Volunteers Phase 1
Completed NCT05074368 - Efficacy and Safety of Heterologous and Homologous COVID-19 Vaccination N/A
Completed NCT01672242 - Assessment of End Expiratory Lung Volumes in Healthy Subjects Using High Flow Oxygen (Vapotherm®) N/A
Completed NCT03878693 - 4-methylpyrazole and Acetaminophen Metabolism Early Phase 1
Completed NCT04204772 - A Pilot Feasibility Study of Activated Charcoal in Healthy Volunteers Early Phase 1
Completed NCT05154461 - Intestinal Ketone Bodies Interfere With the Glycemic Control N/A